Problem Statement
Traditional site-based clinical trials faced challenges such as limited reach, high costs, prolonged timelines, significant patient burden due to frequent site visits, and data fragmentation. The need for patients to travel frequently to trial sites led to higher dropout rates and limited participation from diverse and rural populations.
Existing Technology & Challenges
Traditional site-based EDC systems with manual data entry, limited scalability for remote trials, and lack of real-time data access.
New Technology Introduced
- Hybrid Recruitment of 4,000+ participants (site-based, community-based, online internet-based)
- Unified data management integrating wearables data, PROs, eCRFs,CRM, CMS, remote diagnostic test kit data, and engagement data
- Automated workflows for real-time data collection
- Automated collection of bio-specimen remotely
- Automated patient engagement
- Remote eConsent
- Real-time data analysis and comprehensive dashboards
- Advanced Data Security and Privacy compliance – and Privacy compliance – HIPAA, NIST, FISMA, FIPS, SOC 1 and 2 Type II, PCI DSS, and FedRAMP compliant
Key Outcomes
- Expand participant diversity
- Reduce operational costs
- Ensure regulatory compliance for remote trials
- Accelerate data availability for real-time decision-making
Impact Areas
With the introduction of Vibrent Health’s platform, the BARDA-funded hybrid study led by Fred Hutchinson Cancer achieved key outcomes to operationalize a scalable, participant-centered research model that accelerates trial timelines, improves operational efficiency, and enhances the scientific and regulatory utility of real-world data.
Remote biospecimen collection and digital engagement
allow participants to contribute to research from where they live—reducing burden and improving inclusion.
Real-time data integration
from electronic case report forms (eCRFs), electronic patient-reported outcomes (ePROs), wearables, remotely self-collected specimen metadata, shipping/tracking data to the patients’ homes, lab data (Labcorp), and operational metrics.
Advanced analytics and dashboards
for site-level tracking of enrollment, diversity goals, and adverse events, providing visibility across all sites including data reconciliation reporting with specimen data.
Centralized research data management
ensures transparency for sponsors and site staff and reproducibility of data for researchers including collecting and storing data from partner systems including Labcorp. We maintain a history of all collected data.
Streamlined clinical operations
through a unified digital infrastructure, enabling more efficient execution of a large-scale, multi-site hybrid study.
Time Efficiency Gains
- Database provisioning to first patient data entry achieved in 54 days, compared to industry average of 68 days (Tufts Center for the Study of Drug Development).
- 95% reduction in site visits due to mostly remote study design.
- With integrations with FedEx, UPS, USPS the study achieved transparency in shipping and tracking packages to and from patients’ home which makes the remote automated workflows impossible.
User Experience
- Enhanced mobile and web access for participants.
- Multi-lingual support.
- Simplified and intuitive interfaces for study staff and participants.
Cost Savings
- Cost per participant reduced from an estimated $15,000 (site-based) to $8,500 (remote), resulting in $26 million in savings for a 4,000-participant trial because of the remote study design.
- Reduced travel, site management costs, and site visit associated costs.
Health Economic Impact
- Improved cost-effectiveness by lowering per-participant costs and reducing overhead.
- Facilitated faster data access for decision-making.
Clinical Research Impact
- Enhanced data integrity through automated data capture.
- Increased diversity in recruitment.
- Real-time dashboards enabled continuous monitoring of key metrics.
Regulatory & Compliance Impact
- HIPAA, NIST, FISMA, FIPS, SOC 1 and 2 Type II, PCI DSS, and FedRAMP compliance for data security and privacy.
Scalability & Future Enhancements
- Expansion to support additional remote trials across multiple therapeutic areas.
Lessons Learned
- Importance of real-time data for adaptive trial management.
- Continuous participant engagement is critical to minimize dropout rates.
“This BARDA study expands access, enhances data quality, and accelerates the development of next-generation therapeutics and treatments. By identifying and validating correlates of protection, this research not only informs the development of more targeted and effective treatments for infectious diseases but also establishes a framework that can be applied to a wide range of clinical trials, improving outcomes and speeding up the path to approval.”
— Peter Gilbert, Principal Investigator, Fred Hutch Cancer Center
“Advancing clinical research requires a broad approach that allows for remotely collected real-world data while streamlining clinical operations to enhance efficiency and accelerate research outcomes. Vibrent Health’s technology makes these advances possible in an integrated way this is operationally efficient and leads to high quality results.”
— Jessica Andriesen, Director of Operations, Statistical and Data Coordinating Center, Fred Hutch Cancer Center
